[Toughy]

The reason Gilead is going to FDA for approval of this new use as prevention is so insurance companies will pay for the drug. It is very rare that an insurance company will pay for what is called 'off-label' use. 'Off-label' means the drug is not approved by the FDA for that use.

Truvada is currently approved for treatment but not prevention. If the FDA follows the advisory committee recommendation and approves it for prevention.............BINGO...health insurance will add it to their drug formularies for prevention and pay for it. This has HUGE profit potential for Gilead. Imagine how many people taking it daily for years....$$$$$$$$$

Now lets get to the brass tacks of the problem..........compliance....you must take it every day without fail...period. full stop. No one I know is ever 100% compliant with prescriptions for anything ever. AND if you are not compliant and end up HIV infected then you will have 50/50 chance of a drug resistant strain. It cuts down the number of antivirals available by 3 drugs. And then if you don't have health insurance and rely on Medicare/Medicaid/AIDS Drug Assistance Programs you are in even bigger trouble especially since ADAPs across the country are being gutted by budget cuts.

I'm not so sure it's an amazing possibility for those hardest hit by new infections. Barrier protection is still the best way to prevent infection...... either male condoms or female condoms, dental dams, etc.

And I haven't even addressed the issue of side effects of this combination of 3 drugs. I'm out of the loop so I don't know what this 3 drug cocktail (in one pill) has for a side effect/adverse events profile.

I do believe it should be approved, however serious education and strategies must be developed....barrier precautions plus truvada certainly looks to be good prevention as long as folks understand the danger of not taking your pill and use condoms.

ps...............there are at least 13 individual anti-viral drugs on the market....I actually think there are more than that now...it's a big tool box.....